Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Clinical healing of an anal fistula
研究概览
简要总结
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
详细描述
: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.
Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.
Evaluations :
- Fistula clinical healing 6 and 12 months after procedure
- Fistula MRI healing 12 months after procedure
- Anal continence before and after procedure
- Feasibility og radiofrequency procedure
- Morbidity
- Success and failure prognostics factors of this procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patient agreeing to participate in the study and signing the consent to participate
- •Patients with an anal fistula previously drained, without diverticulum> 10 mm in MRI after drainage.
- •For women of childbearing age, they must have a negative urine pregnancy test
排除标准
- •Patient minor,
- •Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
- •Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
- •Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
- •Pregnant woman,
- •Patient carrying a pacemaker,
- •Patients participating in another clinical study,
- •Against indication to the realization of an MRI,
- •Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).
研究组 & 干预措施
Anal fistula treated by radiofrequency
treatment by radiofrequency: patient with anal fistula treated by radiofrequency
干预措施: treatment by radiofrequency (Procedure)
结局指标
主要结局
Clinical healing of an anal fistula
时间窗: 6 month
Clinical healing of an anal fistula, 6 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow.
次要结局
- evaluate anal continuation(12 months)
- Determination of the optimal settings(12 months)
- Assessment of Feasibility of anal fistula treatment by radiofrequency(day 0 at inclusion)
- Evolution in MRI(12 month)
- Clinical healing of an anal fistula,(12 months)
- Prognostic factors(12 month)
- Patient satisfaction(12 months)
- the rate and nature of post-operative complications(12 months)